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BD (Becton, Dickinson and Company) Quality Compliance Lead in BD Research Centre Ireland (inactive), Ireland

Job Description Summary

BD is recruiting a Quality Compliance Lead to provide quality compliance support to the Worldwide Infusion Specialty Disposables (WWISD) portfolio of products. You will be responsible for overseeing and participating in day-to-day compliance activities relating to product situation analysis, notification and evaluation of incidents, competent authority inquiries and follow up, field actions and Quality Management System process integration and alignment. You will proactively address WWISD compliance needs for products and processes in EMEA and other geographies outside the U.S. (as applicable).

Job Description

As Quality Compliance Lead , you will,

  • Lead the resolution of current WWISD compliance issues as assigned by the Senior Director EMEA Quality Compliance

  • Support integration of new business acquisition processes and procedures into the existing BD model; identify and implement optimization opportunities

  • Manage relationships with competent authorities, ensuring deliverables and timelines are met

  • Assess reported events to determine regulatory reportability; prepare vigilance/regulatory reports as well as communications to Competent Authorities, as required

  • Liaise with and support US colleagues regarding US FDA reporting for products holding US FDA 510(k) clearance

  • Work with business leaders on identified projects and support key business goals and objectives

  • Participate in the preparation and execution of FSCA/FSN for impacted products

  • Escalate high-priority issues as well as identified business risks to the Senior Director EMEA Quality Compliance and other relevant management

  • Support and participate in audits performed by internal and external (e.g. Notified Body) representatives

  • Represent WWISD Quality at scheduled risk management and business meetings

The successful candidate will be educated to degree level in a Science related area or equivalent experience and have demonstrated clinical knowledge and experience in medical device and QA and/or RA, preferably in compliance-based roles. You will have an in-depth knowledge of European Medical Device Directive and the new Medical Device Regulation, experience in Adverse Event handling in accordance with applicable MEDDEV and FDA guidance as well as other European/Emerging Market/international geography regulatory requirements for post market activities. You will have demonstrable experience dealing with competent authorities and other regulatory bodies. You will have project management and/or process change (process improvement) experience with the ability to simultaneously work on multiple projects/activities of various disciplines.

You will have the ability to critically think, solve problems (i.e. solution seeker) and meet deadlines. You will have a conscientious, detail-orientated approach to work

If you’re a team player who is passionate about manufacturing and ‘advancing the world of health’ and we’ve just described your career aspirations, then please APPLY.

interested in a career with BD, but this position doesn’t fit your skills and experience?

Join our talent community here. emea.jobs.bd.com

Primary Work Location

GBR Winnersh - Eskdale Road

Additional Locations

IRL - BD Research Centre Ireland (inactive)

Work Shift

BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.

Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com

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